NCT07588958

Brief Summary

Severe postoperative pain following total knee arthroplasty (TKA ) has been shown to negatively affect early mobilization, physical rehabilitation, time to discharge, and overall post-operative recovery.Therefore, reducing postoperative pain and early mobilization has become critical in reducing early mortality, preventing future chronic pain, and limiting the use of opioids The adductor canal block (ACB) has been found to be an excellent alternative to the FNB, providing adequate analgesia to the anterior knee compartment while enabling an improved postoperative range of motion by sparing motor branches to the quadriceps muscles . However, patients do not achieve adequate posterior knee analgesia as ACB pain relief is primarily limited to the anterior capsule of the knee. Genicular nerve block (GNB) and radiofrequency ablation of genicular nerves (RFGN) were originally introduced by Choi et al. as a therapeutic alternative for chronic knee OA and were quickly adopted for use in patients undergoing TKA due to the significant pain reduction and functional improvement observed in these patients . GNBs target five main innervating branches of the knee, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Oct 2023Jun 2026

Study Start

First participant enrolled

October 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2026

Expected
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 9, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

genicular nerve blockAdductor canal blockpostoperative analgesiatotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • changes of pain assessment

    visual analogue scale

    time frame ( at PACU, 2 hours (h ) , 4 , 8 , 12 , 16 , 24 hours postoperatively )

Secondary Outcomes (1)

  • Modified Bromage scale

    at PACU, 3 hours and 6 hours postoperatively

Study Arms (3)

control group

OTHER

Receive spinal anesthesia

Other: Spinal Anesthesia with Bupivacaine and Fentanyl

Genicular nerve block group

ACTIVE COMPARATOR

Receive Genicular Nerve Block

Other: Genicular nerve block with bupivacaine

Adductor canal block group

ACTIVE COMPARATOR

Receive Adductor canal block

Other: Adductor Canal Block (ACB) Only

Interventions

spinal anesthesia will be given (under complete aseptic conditions) at the level of L3/4 while the patient in the sitting position using a spinal needle 25 G x 3.5 inches with injection of hyperbaric bupivacaine 0.5% 3ml plus fentanyl 25 microgram .

control group

For the superomedial genicular nerve, a linear transducer will be placed along the longitudinal plane of the femur to visualize vastus medialis, the distal femur, and the genicular artery. Using an in-plane technique, a 10-cm echogenic 21-gauge needle will be advanced in the cephalad to the caudad direction until the needle contacted femoral shaft, just cephalad to the genicular artery, and 5 ml of 0.25% bupivacaine will be injected to spread along the femoral periosteum. This same technique, using 5 ml of 0.25% bupivacaine, will be used in a mirror image on the lateral epicondyle to block the superolateral genicular nerve. To target the inferomedial genicular nerve, a linear transducer will be placed in the sagittal plane on the anterior medial tibia.

Genicular nerve block group

The transducer will be placed anteromedially midway between inguinal crease and medial condyle to identify sartorius muscle. Probe will be positioned perpendicular to the femoral artery and using in-plane technique with needle directed from lateral to medial to deposit local anesthetic under sartorius and around the femoral artery. 15ml bupivacaine 0.25% will be injected

Adductor canal block group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient acceptance.
  • Sex: both; male and female.
  • Age: over 65 years old.
  • American society of anesthesiologists (ASA): II .
  • Body mass index (BMI) less than 35 kg/m2.
  • Operation : elective unilateral TKA.
  • Duration of surgery : 2-3 hours.

You may not qualify if:

  • History of allergy to local anesthetics (lidocaine or bupivicaine).
  • Coexisting hematologic disorders or malnourished patient.
  • Pre-existing major organ dysfunction including hepatic or renal failure, and left ventricular ejection fraction \<30%
  • Peripheral neuropathy.
  • Patients with a diagnosis of cognitive impairment or significant psychiatric illness.
  • Skin infection at site of block.
  • Contraindication to spinal anesthesia as coagulopathy and infection at site of injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine - Zagazig University

Zagazig, Alsharqia, 4115, Egypt

Location

MeSH Terms

Interventions

Anesthesia, SpinalBupivacaineFentanylSingle Person

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Soha Saad mohamed Hassouna, PHD

    Faculty of medicine - zagazig university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double ( participant, outcomes assessor) double-blinded ( participant, outcomes assessor)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of anesthesia and surgical intensive care and pain managment

Study Record Dates

First Submitted

May 9, 2026

First Posted

May 15, 2026

Study Start

October 1, 2023

Primary Completion

May 6, 2026

Study Completion (Estimated)

June 19, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Planned after completion of the study and publications

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Planned after completion of the study and publications
Access Criteria
Contact with principal investigator

Locations